Pediatric Elective Intubation With and Without Muscle Relaxation Utilizing the Shikani Optical Stylet

The investigators' primary specific aims are to demonstrate that:

1. Pediatric patients with normal airways, undergoing elective surgical procedures, can be successfully intubated when deeply sedated, without the use of muscle relaxants using the Shikani Optical Stylet.

2. Shikani intubation of pediatric patients is equally effective in children that are deeply sedated or paralyzed as evidenced by a non-significant difference in:

   • Time to intubation (defined as no more than a 30 second time difference between the two groups);
   • Incidence of adverse events.

Study Overview

• Status: Terminated
• Conditions: Intubation,Endotracheal
• Intervention / Treatment: Drug: Normal saline; Drug: Cisatracurium

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Rady Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 6 months of age to 17 years of age (not yet 18)
• Male or female
• English or Spanish speaking
• Normal airway (Mallampati Classification )
• American Society of Anesthesiology Physical Status Classification I or II
• Elective surgical procedure expected to last at least 45 minutes in length
• Written informed consent/assent for participation given by the parent legal guardian and subject (if applicable)

Exclusion Criteria:

• < 6 months of age, > 17 years of age
• Difficult airway (Mallampati Classification)

• History of previous difficult intubation, suspected abnormal airway: *micrognathia

  • facial trauma
  • airway tumor
  • epiglottitis
  • retropharyngeal abscess
  • foreign body, etc.
  • Scheduled for non-elective, emergent OR procedure
  • Parent, legal guardian, or subject is unavailable or unwilling to consent for study participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Normal saline; Normal saline volume calculated to be equal to the volume of cisatracurium 0.2mg/kg	Drug: Normal saline; One Intravenous dose
Active Comparator: Cisatracurium; Subjects in this arm will be given Cisatracurium 0.2mg/kg IV dose one time prior to intubation.	Drug: Cisatracurium; One intravenous dose: 0.2mg/kg/dose; Other Names: Nimbex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Intubation	Time to intubation was defined as the time (seconds) required to verify three breaths on an end-tidal carbon dioxide monitor.	Confirmed by the visualization of three carbon dioxide waveforms.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Adverse Events	The number of occurrences of each event. One subject may have multiple adverse events.	Recorded from the start of the intubation procedure to the time of successful endotracheal intubation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Intubation Attempts for Each Enrolled Subject	The total number of intubation attempts to achieve successful intubation of study participants.	The number is totaled after successful endotracheal intubation is documented

Collaborators and Investigators

• Sponsor: Rady Children's Hospital, San Diego

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: June 1, 2009
• First Submitted That Met QC Criteria: June 1, 2009
• First Posted (Estimate): June 3, 2009

Study Record Updates

• Last Update Posted (Actual): August 18, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Pediatric
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Blocking Agents; Cisatracurium
• Other Study ID Numbers: 11672; 06104C (Other Identifier: Rady Children's Hospital San Diego)